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22:05 EDT 28th July 2016 | BioPortfolio

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Hydrocodone bitartrate ER regulatory update

Vantrela ER hydrocodone bitartrate regulatory update

Teva's pain treatment recommended for FDA approval

Teva Pharmaceutical Industries' twice-daily tablet Vantrela ER, or hydrocodone bitartrate, has been endorsed for approval by  -More- 

Teva Gains Recommendation for Approval from FDA Advisory Committees for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

JERUSALEM--(BUSINESS WIRE)--Jun. 7, 2016-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety ...

FDA panels recommend Teva's Vantrela ER

FDA's Anesthetic and Analgesic Drug Products committee and Drug Safety and Risk Management advisory committee voted 14-3 to recommend approval of Vantrela ER hydrocodone bitartrate (CEP-33237) from Te...

Report: Prescriptions for Hydrocodone-containing Combination Drugs Drop

The switch of hydrocodone-containing combination drugs from Schedule III to the more restrictive Schedule II in October 2014 significantly reduced the number of prescriptions filled for these drugs, a...

Collegium unveils positive topline results for Hydrocodone DETERx clinical study

Collegium Pharmaceutical has unveiled positive topline results from a clinical study evaluating Hydrocodone DETERx as a second product candidate using its proprietary DETERx drug delivery technology p...

FDA panels to discuss two more pain products

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will meet in June to discuss pain candidates CEP-33237 from Teva Pharmaceutical Industries Ltd. (NY...

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Single-dose pharmacokinetics of 2 or 3 tablets of biphasic immediate-release/extended-release hydrocodone bitartrate/acetaminophen (MNK-155) under fed and fasted conditions: two randomized open-label trials.

Biphasic immediate-release (IR)/extended-release (ER) hydrocodone bitartrate (HB)/acetaminophen (APAP) 7.5/325-mg tablets are formulated with gastroretentive ER drug delivery technology that has been ...

A pharmacokinetic evaluation of single and multiple doses of extended-release hydrocodone bitartrate in subjects experiencing surgical or osteoarthritic pain.

To assess the single-dose and steady-state pharmacokinetics of a single-entity hydrocodone extended-release (ER) formulation in patients enrolled in two separate phase 2 clinical studies.

Pharmacokinetic Profile and Sustained 24-hour Analgesia of a Once-daily Hydrocodone Bitartrate Extended-release Tablet with Abuse-deterrent Properties.

The purpose of this study was to evaluate the pharmacokinetics (PK) and 24-hour analgesic effectiveness of once-daily, single-entity, extended-release hydrocodone (HYD) with abuse-deterrent properties...

Relationship between change in pain intensity and functional outcomes in patients with chronic pain receiving twice daily extended-release hydrocodone bitartrate.

Evaluate levels of pain relief achieved in patients with chronic pain treated with hydrocodone-extended release (HC-ER) up to 48 weeks and show that these levels were associated with secondary functio...

Opioid Treatment Patterns Following Prescription of Immediate-Release Hydrocodone.

Immediate-release (IR) hydrocodone is the most widely prescribed opioid in the United States; however, little is known about the utilization patterns and duration of opioid use among patients prescrib...

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